Master of Science in Health Sciences in Leadership and Strategy in Regulatory Affairs and Clinical Research Administration

The regulation of clinical research is in itself a dynamic and emergent field. It brings together the science in which products—drugs, devices, biologics and vaccines—and treatment protocols are developed for improved global health care. Both the master’s degree and graduate certificate programs prepare scientists and regulatory professionals to manage the key elements of the clinical research regulatory process. The rigorous curriculum focuses on regulatory strategy, regulatory guidance, legal and ethical issues, processes for product development and the business and political components of regulation in clinical research, all while reinforcing the science behind the methods. Program graduates develop knowledge and skills in regulatory strategy and clinical conduct to guide the development of new therapeutics. 

The distance education format provides a contemporary option for self-directed professionals who work in the field with industry or who may be just entering the field with one of the health and human services agencies charged with providing oversight and guidance to industry. Our course work has been developed in partnership with colleagues in industry and public regulatory agencies. The core courses will provide our students with the foundation to support new product development based on the conduct and regulation of clinical trials including registration by health authorities and strategies to manage product updates  and post-approval commitments. The curriculum is taught by faculty members who bring both the perspectives of the sponsor and those of public health agencies.

As a result, the program provides each graduate with a robust academic education, while giving the student access to key leaders and practitioners in regulatory affairs and clinical research. This program has been strategically designed to generate leaders who will meet the needs of the emerging trends in regulatory affairs. 

Visit the program website for additional program information.

Adminssion Requirements

Article	Requirement
Admissions Deadlines:	Fall - August 6
	Spring - December 6
	Summer - March 15
	The application and all supporting documentation (fees, statement of purpose, letters of recommendation, transcripts) must be received by the deadline in order for the application to be reviewed.
Standardized Test Scores:	Not required
Recommendations required:	Two (2) recommendations
Prior Academic Records:	Transcripts required from all colleges and universities attended, whether or not credit was earned, the program was completed, or the credit appears as transfer credit on another transcript. Transcripts must be forwarded in their original sealed envelopes.
	If academic records are in a language other than English, a certified English language translation must be provided in addition to the original transcripts; translations alone will not be accepted.
	Official transcripts from institutions outside the U.S. must be accompanied by an official transcript evaluation from an accredited independent evaluating agency. Please be sure you request a detailed evaluation that includes all course titles, credit hours, grades, U.S. degree equivalency, grade-point averages (GPA), and date of degree conferral. For a list of acceptable foreign credential evaluation services, please follow this link: https://www.naces.org/members.
Statement of Purpose:	In an essay of 250 to 500 words, describe your reasons for undertaking study in the Health Sciences at The George Washington University. You should state your academic objectives, career plans, and related qualifications, including collegiate, professional, and community activities, as well as any other substantial accomplishments not already mentioned on the application form.
Degree and GPA Requirements	Bachelor’s degree from a regionally accredited institution
	3.0 GPA or above on a 4.0 scale
International Applicants:	Please follow this link - https://graduate.admissions.gwu.edu/international-student-application-requirements - to review the International Applicant Information carefully for details on required documents and English language requirements.
	PLEASE NOTE that the Health Sciences programs require the following minimum English language test scores for admission:
	- Academic IETLS: an overall band score of 7.0 with no individual band score below 6.0; or
	- TOEFL: 600 on paper-based, 250 on computer-based, or 100 on Internet-based; or
	- PTE Academic: 68

Supporting documents not submitted online should be mailed to:

George Washington University 
ATTN: Transcript Processing Center 
8300 Norman Center Dr 
Suite 400 
Bloomington, MN 55437 

Alternatively, official electronic transcripts can be sent to transcripts@hsprograms.gwu.edu.

Contact for questions:

hsphora@gwu.edu
202-994-0384 (phone)
202-994-0870 (fax)
Hours: 9 am to 5 pm, Monday through Friday

The following requirements must be fulfilled: 36 credits, including 21 credits in required core courses and 15 credits in required and elective courses in either the regulatory affairs concentration or the clinical research administration concentration.

Course List

Code	Title	Credits
Required core courses
HSCI 6264	Epidemiology Translational Research
COHM 6235	Leadership Development in Healthcare Systems
COHM 6245	Strategic and Operational Decision Making for Healthcare Leaders
RCR 6201	Introduction to Global Regulatory Affairs and Clinical Research
RCR 6202	Regulatory Strategy in the Development of Therapeutics
RCR 6206	International Regulatory Affairs and Clinical Research
RAFF 6275	Leadership in Regulatory Affairs
or CRA 6275	Leadership and Change in Clinical Research Administration
Concentration requirements
Students must complete all requirements for either the regulatory affairs concentration or the clinical research administration concentration, as follows:
Regulatory affairs concentration
RAFF 6203	Regulatory Strategy in the Development of Devices and Diagnostics
RAFF 6204	Clinical Research for Regulatory Affairs
RAFF 6205	Regulatory Affairs Compliance
RAFF 6207	Advertising and Promotion of Regulated Medical Products
And one course selected from the following:
CRA 6203	Partnerships with Human Subjects
CRA 6209	Quality and Risk Management
CRA 6211	Monitoring, Auditing, and Oversight in Clinical Research
HSCI 6263	Biostatistics Translational Research
Clinical research administration concentration
CRA 6203	Partnerships with Human Subjects
CRA 6204	The Clinical Research Industry
CRA 6209	Quality and Risk Management
CRA 6211	Monitoring, Auditing, and Oversight in Clinical Research
And one course selected from the following:
HCQ 6201	Building a Quality Culture
HSCI 6263	Biostatistics Translational Research
RAFF 6204	Clinical Research for Regulatory Affairs
RAFF 6205	Regulatory Affairs Compliance
RAFF 6207	Advertising and Promotion of Regulated Medical Products